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| United States Patent |
5,576,001
|
|
Abu-Shaaban
|
November 19, 1996
|
Composition for the treatment of diarrhea, its use and its preparation
Abstract
A composition for treating diarrhea comprises carrots, rice, bananas and
glucose in powdered form, the carrots and rice having been cooked and
dried prior to being ground to a powder. The composition may also contain
one or more of powdered pineapple, apples, soybeans and maltodextrin. An
effective amount of the composition is administered to a patient, such as
an infant, to treat and alleviate diarrhea.
| Inventors:
|
Abu-Shaaban; Medhat (8529 Huntspring Dr., Lutherville, MD 21093)
|
| Appl. No.:
|
392422 |
| Filed:
|
February 22, 1995 |
| Current U.S. Class: |
424/750; 424/773; 424/777; 514/868 |
| Intern'l Class: |
A61K 035/78 |
| Field of Search: |
424/195.1
514/868
|
References Cited
U.S. Patent Documents
| 4950140 | Aug., 1990 | Pflaumer et al. | 424/439.
|
| 5013576 | May., 1991 | Nakazawa et al. | 426/640.
|
| 5132113 | Jul., 1992 | Luca | 424/195.
|
| Foreign Patent Documents |
| 5-286863 | Nov., 1993 | JP | .
|
Primary Examiner: Rollins; John W.
Attorney, Agent or Firm: Lowe, Price, LeBlanc & Becker
Claims
I claim:
1. A therapeutic composition for the treatment of diarrhea comprising
carrots, rice, bananas and glucose in powdered form, the carrots and rice
having been cooked and dried prior to being ground to a powder.
2. The composition of claim 1 also including pineapple in a dried and
powdered form.
3. The composition of claim 2 also including soy beans in a dried and
powdered form.
4. The composition of claim 3 also including apples in a dried and powdered
form.
5. The composition of claim 1 also including soy beans in a dried and
powdered form.
6. The composition of claim 1 also including apples in a dried and powdered
form.
7. The composition of claim 1, wherein the carrots are present in a range
of about 40 to about 60% by weight based on the entire composition.
8. The composition of claim 1 wherein maltodextrin is also present, in an
amount of about 0.5 grams based upon a combined weight of the other
components in the range of about 70 to about 120 grams.
9. The composition as in claim 1 comprising said carrots, rice, bananas and
glucose in the following amounts:
40 g carrots;
10 g rice;
10 g glucose;
15 g bananas;
and further comprising maltodextrin and dried and powdered pineapple in the
following amounts:
5 g pineapple; and
0.5 g maltodextrin.
10. The composition as in claim 1 comprising said carrots, rice, bananas
and glucose in the following amounts:
40 g carrots;
10 g rice;
5 g glucose;
15 g bananas;
and further comprising 0.5 g maltodextrin.
11. The composition as in claim 1 comprising said carrots, rice, bananas
and glucose in the following amounts:
40 g carrots;
20 g rice;
10 g glucose;
15 g bananas;
and further comprising maltodextrin and dried and powdered pineapple, soy
beans and apples in the following amounts:
5 g pineapple;
5 g soy beans;
15 g apples; and
0.5 g maltodextrin.
12. The composition as in claim 1 comprising said carrots, rice, bananas
and glucose in the following amounts:
40 g carrots;
20 g rice;
10 g glucose;
15 g bananas;
and further comprising maltodextrin and dried and powdered soy beans in the
following amounts:
5 g soy beans; and
0.5 g maltodextrin.
13. A process for preparing a therapeutic composition as recited in claim 1
wherein
carrots are cleaned, sliced and boiled in water until tender; then vacuum
dried with minimal heat; and ground into a fine powder;
rice cereal is vacuum dried with minimal heat, like the carrots, and ground
to a fine powder;
bananas are dried and ground into a fine powder; and
the carrots, rice, bananas and glucose are mixed together and further
ground to a fine powder.
14. A method for treating and alleviating diarrhea by administering to a
patient suffering from diarrhea a therapeutically effective dose of a
composition as defined in claim 1.
15. A method as set forth in claim 14 wherein the composition also includes
pineapple in a dried and powdered form.
16. A method as set forth in claim 14 wherein the composition also includes
soy beans in a dried and powdered form.
17. A method as set forth in claim 14 wherein the composition also includes
apples in a dried and powdered form.
18. A method as set forth in claim 14 wherein the composition is
administered in a carrier selected from the group consisting of a
sweetened aqueous drink and non-fat yogurt.
19. A method as set forth in claim 14 wherein the composition is
administered mixed with food.
20. A method as set forth in claim 14 herein the composition is
administered mixed with mother's milk.
21. A method as set forth in claim 14 wherein the patient is a human being.
22. A method as set forth in claim 21 wherein the patient is an infant.
23. A method as set forth in claim 21 wherein the patient is a child.
24. A method as set forth in claim 21 wherein the patient is an adult.
25. A method as set forth in claim 14 wherein the patient is a warm blooded
animal.
26. A method as set forth in claim 25 wherein the animal is a horse.
27. A method as set forth in claim 25 wherein the animal is a dog.
28. A method as set forth in claim 25 wherein the animal is a parrot.
29. A method as set forth in claim 14 wherein the composition is
administered in a form selected from the group consisting of powders,
capsules and tablets.
30. A composition for the treatment of diarrhea comprising carrots, rice
and glucose in powdered form, the carrots and rice having been cooked and
dried prior to being ground to a powder, said composition also containing
at least one additional component selected from the group consisting of
pineapple, soy beans and apples in dried and powdered form.
31. The composition of claim 30 wherein the additional component is
pineapple in dried and powdered form.
32. The composition of claim 30 wherein the additional component is soy
beans in dried and powdered form.
33. The composition of claim 30 wherein the additional component is apples
in dried and powdered form.
Description
BACKGROUND OF THE INVENTION
This invention relates to a composition for treating diarrhea, as well as
to the use and to the preparation of said composition. Diarrhea is a
widespread and recurring ailment that attacks adults, children, infants
and warm-blooded animals throughout the world. It has been estimated that
in the United States, 16.5 million children under the age of five years
experience 21-37 million episodes of diarrhea each year, 10% of said
episodes leading to a physician's visit. Over 200 thousand of the children
are hospitalized and 325 to 425 of the children die, most of them infants
under one year of age. On a worldwide basis, next to respiratory
infections, diarrheal diseases are the leading cause of death among
children under five years of age. Thus, it is evident that control of this
condition deserves the attention of the medical and veterinary communities
and is in need of an effective, low-cost, easily administrable therapeutic
agent.
The proper relationship of nutrients, wastes, electrolytes, and water
through the intestines depends on an appropriate balance of absorption and
secretion of water and electrolytes by the intestinal epithelium. However,
there are many forces that interfere with the normal functioning of the
body, leading to diarrhea. These forces may involve infections, chemicals
or radiation, for example, and may reflect the condition of the immune
system, such as in HIV syndrome. The function of the anti-diarrheal agent
generally is not to attack the cause of the condition, but to relieve the
symptoms and discomfort associated with said condition.
The organisms responsible for diarrhea include those that cause amebiasis,
cholera, infectious colitis, and bacteremia (particularly from
Salmonella), in addition to the specific organisms, enterotoxigenic and
invasive Escherichia coli, Giardia lamblia, Isospora belli, Shigella,
Strongyloides stercoralis, and essentially all organisms for which there
is effective antimicrobial therapy causing diarrhea in immuno-compromised
hosts.
Other organisms guilty of producing diarrhea encompass viruses, such as
cytomegalovirus, enteric adenovirus, picornavirus and rotavirus. Also,
various parasites may be responsible for the condition. Included in this
group, in addition to those already mentioned, are Entamoeba histolytica,
cryptosporidium and Microsporidia species.
Some of the chemical agents causing diarrhea are adrenergic neuron blocking
agents, such as reserpine and guanethidine; antimicrobials, such as
sulfonamides, tetracyclines and most broad-spectrum agents; bile acids,
carcinoid tumor secretions, e.g., 5-hydroxytryptamine and vasoactive
intestinal peptide; cholinergic agonists and cholinesterase inhibitors;
fatty acids; osmotic laxatives, such as sorbitol and saline cathartics;
prokinetic agents, such as metoclopramide and domperidone; prostaglandins;
quinidine; and stimulant laxatives.
Notwithstanding the above, in an article in Pediatric Anals 23:523-524
(October 1994), Dr. Robert A. Hoekelman, cautions that:
Non-antimicrobial medications should not be used for the treatment of
diarrhea in infants and children because they provide no benefit and may
worsen the diarrhea by slowing intestinal mobility and thereby the
expulsion of organisms and toxins responsible for the diarrhea, and by
preventing absorption and secretion from the intestinal wall. Some drugs
that slow intestinal motility such as diphenoxylate hydrochloride-atropine
sulfate and loperamide hydrochloride also may cause respiratory
depression, coma, and death.
PRIOR ART
Among the many cures described for diarrhea is that claimed in U.S. Pat.
No. 115,517, involving a composition containing opium, sugar, nutmeg and
brandy. In U.S. Pat. No. 133,213, a similar composition is claimed
consisting of white oak bark, cinnamon, cloves, dandelion root and brandy.
While the first two patents were issued in the last century, more recent
treatment of diarrhea involves the administration of an aqueous extract of
oatmeal, as claimed in U.S. Pat. No. 4,765,981, issued in 1988. On the
other hand, in U.S. Pat. No. 4,261,981, the patentee claims a method for
preparing a composition from ragweed leaves, said composition being useful
for treating diarrhea.
Even more recently, two patents, U.S. Pat. No. 5,149,541 and U.S. Pat. No.
5,234,916, assigned to the Proctor and Gamble Company, are concerned with
treating diarrhea with a psyllium husk-containing drink mix composition
and a divalent cation salt of a strong inorganic acid selected from
magnesium sulfate, calcium sulfate, calcium chloride, zinc sulfate and/or
zinc chloride and a carrier material therefor. In U.S. Pat. No. 5,149,541,
the same type drink mix product is claimed, although the particular
particle size distribution is also recited. Even more recently, U.S. Pat.
No. 5,330,755, issued Jul. 19, 1994, a patent assigned to Nestec S. A.,
contains claims directed to a process for producing a carob product by
treating ground-desugared carob pods with super-heated steam to pasteurize
and dry the carob. The method for treating diarrhea by administering to a
patient particulated carob pod having water-insoluble tannins is claimed
in the assignee's earlier U.S. Pat. No. 5,043,160.
The failure of the foregoing therapeutic agents to be presently
recognizable testifies to their ineffectiveness in controlling diarrhea.
However, several products are currently popular in the United States for
treating this ailment. These products include Imodium.RTM. (loperamide
hydrochloride, a piperidine opioid), Lomotil.RTM. (diphenoxylate
hydrochloride with atropine sulfate, diphenoxylate being related to the
narcotic meperidine), sold by G.D. Searle & Co., and Pepto-Bismol.RTM. (a
bismuth subsalicylate composition) sold by Proctor and Gamble. However,
although the opioids are described in Goodman and Gilmans The
Pharmacological Basis of Therapeutics, Eighth Edition, Pergamon Press, New
York, (1990) at pages 924-925 as being effective in treating
moderate-to-severe diarrhea, it is cautioned that the opioids should not
be used in patients with chronic ulcerative colitis or acute bacillary or
amebic dysentery, since they appear to potentiate ulcerating processes in
the colon and can provoke the development of toxic megacolon.
Many traditional remedies are said to have little or no value in the
treatment of acute infectious diarrhea: these include kaolin, pectin,
lactobacilli and muscarinic antagonists. Clonidine has also been said to
be effective in the treatment of diabetic patients with watery diarrhea
syndrome.
Substances available on the market provide balanced electrolytes to replace
stool losses and provide maintenance requirements. Such products include
Pedialyte.RTM. and Rehydralyte.RTM., sold by Ross Laboratories and provide
water, dextrose, potassium citrate, sodium chloride and sodium citrate.
These compositions are expensive and rarely stocked in homes for immediate
use when diarrhea begins. Therefore, clear liquids like ginger ale, colas,
gelatin, tea, apple juice and chicken broth, none of which contains
appropriate glucose or electrolyte concentrations, are used instead,
possibly doing more harm than good. In any event, unlike the instant
invention, the foregoing pharmaceuticals are not relatively inexpensive
natural substances that have proven to be extremely effective in
eliminating the symptoms of diarrhea.
SUMMARY OF THE INVENTION
The present invention provides a product which is active in the treatment
of diarrhea in humans, including children and infants, as well as in
warm-blooded animals generally, including dogs, horses and birds.
Furthermore, the claimed composition does not have the disadvantages
exhibited by products now on the market.
The invention at hand involves a composition comprising carrots, rice and
glucose prepared in the manner disclosed subsequently. The composition may
also include one or more of bananas, pineapple, soy beans and apples.
Generally, the formulations employed to treat diarrhea comprise about 40
to about 60% by weight dried carrots, about 10 to about 25% by weight
dried, cooked rice, and about 7 to about 15% by weight glucose.
Additionally, 0.5 gram of maltodextrin is included in each formulation to
bind the composition together. However, although the foregoing amounts
have been shown to provide desirable results, the most important
consideration is the effectiveness of the composition. It is expected that
slightly more or less of one component may be employed relative to another
without significantly changing the results reported.
The additional presence of bananas, pineapple, soy beans and/or apples, has
been found to enhance the activity of the composition, in addition to
making the agent more palatable to the patient. Because of the acidity in
pineapple, the percentage weight of this component is maintained at a
relatively low value, as shown in the examples. On the other hand, while
soy beans are found to be helpful, because of their fiber, the taste of
the soy beans is not universally popular. It is this property that
determines the amount of soy bean employed. The weight of the apples
present in any particular formulation would usually approximate that of
the bananas. However, it is important that each of the components, as
indicated below, be cooked, then dried and ground to a fine powder before
being administered to a patient for the treatment of diarrhea.
DETAILED DESCRIPTION OF THE INVENTION
The materials for formulating the anti-diarrheal composition are prepared
as follows:
Carrots--These are cleaned, sliced and placed in water, without salt, until
the water reaches the boiling point. They are cooked for about 10-15
minutes until soft and are then strained and put into a food dehydrator.
The carrots are vacuum dehydrated with a minimum of heat. This may take 24
hours to obtain a completely dry product. The dried carrots are thereafter
ground to a fine powder. However, it has been observed that said powder
has a gritty feel to it when rubbed with the fingers.
Rice Cereal--This ingredient is used in the form obtained as a commercial
preparation, i.e., Gerbers.RTM. rice cereal. It is dehydrated, if not
already adequately dried, and then ground. When the rice is in the form of
a powder, it is added to the carrots and dry blended.
Bananas--Yellow bananas are sliced, dehydrated in a vacuum dehydrator and
ground to a powder. The fruit is dry blended with the other components of
the composition.
Pineapple--The fruit is very thinly sliced and then placed into a vacuum
dehydrator, where water is removed. The dried pineapple is ground to a
powder and added to the other components. Because pineapples have a very
sharp acidic taste, the amount of pineapple, by weight, is limited to
about 5 grams per batch of composition containing about 70 to 120 grams of
material.
Soy beans--These are prepared with the capsule left on. The soy beans are
cooked until soft, then dried and ground. Babies appear to dislike the
taste. While natural flavors have been added to mask the taste, said
flavors usually have excessive sugar and cause problems, in themselves. To
avoid the problems, bananas are added instead of the separated natural
flavors and glucose is used for sweetness. Of course, other readily
digestible sugars may be employed instead of glucose, but might be more
expensive.
Apples--These can be used up to about 15 grams, to improve the
composition's flavor. The apples are sliced, cooked like carrots and then
dehydrated in the vacuum dehydrator. Applesauce is not used because it
exacerbates the diarrhea.
To prepare the composition, a "Gloria Bean Coffee Grinder" was used. As
previously mentioned, everything was ground to a fine powder. The carrots,
as already noted, tended to be a little gritty. However, even with the
carrots, most of it becomes a fine powder. The composition containing a
vegetable, a grain and a fruit, including the carrots and rice, has been
found particularly beneficial.
ADMINISTRATION
The powdered composition can be administered to an infant as an addition to
a formula, with a flat soda, like a cola or ginger ale, or with plain
non-fat yogurt. Plain yogurt, although a dairy product, used in small
amounts, with the formulation, is effective in controlling diarrhea in
infants. However, there is no real restriction on how the formulation is
given to the patient. If a distasteful carrier or component is avoided,
the patient will more likely ingest the composition. It is critical to the
effectiveness of the invention that the patient swallow the composition.
Although the composition has been used primarily to control diarrhea in
infants, young children and adults, it has also been used for the same
purpose with animals. Newborn horses sometimes develop diarrhea within
nine days of birth. Previously, they have been administered
Pepto-Bismol.RTM. in relatively large quantities. On the other hand, two
doses of the instant product (4 tablespoons for the first dose and a
lesser amount for the second dose) stop the diarrhea in the newborn horse.
In medicating a young foal, two tablespoons of the composition were mixed
with warm water and given with a bottle. However, because the horse
refused to swallow the composition, the product was mixed with mare's milk
and given through a tube into the horse's stomach. This stopped the
diarrhea.
A dog was likewise treated with the present product with similar results.
The product stopped the diarrhea.
A parrot suffering from diarrhea was given a little bit of the formulation
with some food. The same type of results were obtained wherein the
diarrhea was alleviated.
Several different formulations have been found to be effective in stopping
diarrhea and to be readily accepted by patients. These products are
described in the following examples:
EXAMPLE 1
The listed ingredients were prepared as previously described and were
formulated into a composition in the amounts indicated.
______________________________________
Carrots 40 grams
Rice cereal 10 grams
Bananas 15 grams
Pineapple 5 grams
Glucose 10 grams
Maltodextrin 1/2 gram
______________________________________
EXAMPLE 2
______________________________________
Carrots 40 grams
Rice cereal 10 grams
Bananas 15 grams
Glucose 5 grams
Maltodextrin 1/2 gram
______________________________________
EXAMPLE 3
______________________________________
Carrots 40 grams
Rice cereal 20 grams
Pineapple 5 grams
Glucose 10 grams
Maltodextrin 1/2 gram
______________________________________
EXAMPLE 4
______________________________________
Carrots 40 grams
Rice cereal 20 grams
Soy beans 15 grams
Glucose 10 grams
Maltodextrin 1/2 gram
______________________________________
EXAMPLE 5
______________________________________
Carrots 40 grams
Rice cereal 20 grams
Soy beans 5 grams
Bananas 15 grams
Pineapple 5 grams
Glucose 10 grams
Apple 15 grams
Maltodextrin 1/2 gram
______________________________________
EXAMPLE 6
______________________________________
Carrots 40 grams
Rice cereal 20 grams
Soy beans 5 grams
Bananas 15 grams
Glucose 10 grams
Maltodextrin 1/2 gram
______________________________________
EXAMPLE 7
______________________________________
Carrots 40 grams
Rice cereal 20 grams
Soy beans 5 grams
Pineapple 5 grams
Glucose 10 grams
Maltodextrin 1/2 gram
______________________________________
In addition, apple can be substituted for banana and pineapple may be used
in small amounts in each of the formulations.
DOSAGE
Since the composition is composed of all natural products, there is no
question of toxicity to the patient. In humans, the dosage depends upon
the age of the patient. Infants are fed 1/2 teaspoon of the formulation
with fluid, while children, adults and large animals are administered
proportionately more, as shown below:
Dosages in humans, administered three times daily:
______________________________________
Age Amount
______________________________________
0-3 months half teaspoon
3-6 months 1 teaspoon
6-12 months 1 1/2 teaspoon
1-2 years 2 teaspoon
2-6 years 1 tablespoon
6-12 years 1 to 1 1/2 tablespoon
greater than 12 years
2 tablespoon
______________________________________
The powder is given to a patient experiencing a loose bowel movement.
Veterinary dosages depend to a great extent on the animal's size. Where the
animal is under ten pounds, one half teaspoon of the composition is
administered. In larger animals, the dosage depends on the size and
severity of the condition.
The form of the composition is not limited to a powder. It may also be
given as a capsule or as a tablet. The capsules include any form of
conventional capsules, such as those made of gelatin, and the tablets are
those conventionally used in the pharmaceutical field. The tablets may be
chewing tablets or other types that the patient is found to prefer. Also,
the powder may be placed in a compatible liquid and offered for sale or
administration in this form. The powder, if kept in a freezer, will
maintain its effectiveness over a long period of time. Powder placed in a
freezer for almost a year was still effective in treating a case of
diarrhea.
When the composition is administered to a patient, it cures the symptoms of
diarrhea, which usually do not recur. The mechanism whereby this takes
place is not understood, but it has been documented by patients who have
been so treated. The same phenomenon, i.e., the non-recurrence of
symptoms, is not experienced in all animals. Because it could not be
determined whether the specific size of the powder particles contributed
to the activity of the composition, the particles were measured and found
to have a particle size distribution as shown below.
______________________________________
Nominal mean Mesh Amount retained or
Example No.
particle size (.mu.m)
size passed through (%)
______________________________________
1 148 .gtoreq.60
25.27
.ltoreq.270
26.13
2 178 .gtoreq.60
30.29
.ltoreq.270
22.30
3 149 .gtoreq.60
25.12
.ltoreq.270
25.58
4 168 .gtoreq.60
23.4
.ltoreq.270
16.26
5 131 .gtoreq.60
17.95
.ltoreq.270
24.81
6 162 .gtoreq.60
22.45
.ltoreq.270
16.04
7 182 .gtoreq.60
24.8
.ltoreq.270
15.41
______________________________________
The nominal mean particle size was determined from the sieve analysis data
by using the Sigmaplot for Windows (version 2.0).
From the foregoing data, it is apparent that the size of the powder
particles is between 131 and 182 microns, the average being about 160
microns.
Notwithstanding the compositions' freedom from toxic effects, it is not
prescribed for patients experiencing very high fever, lethargy and bloody
diarrhea. These symptoms are indicative of bacterial diarrhea, as well as
bacteremia and sepsis, thus raising a suspicion of other severe systemic
disorders. However, in the usual case of diarrhea, as previously
described, the composition is quite effective and its use is free from
adverse effects.
Only the preferred embodiment of the invention and but a few examples of
its versatility are shown and described in the present disclosure. It is
to be understood that the invention is not only capable of use in various
other combinations and environments, but also of changes or modifications
within the scope of the inventive concept as expressed herein.
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